Opatanol - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn.
olopatadine
Post-authorisationHuman
Opatanol nasal spray is a solution containing 6 mg/ml of the active substance, olopatadine (as the hydrochloride).
Opatanol has been authorised in the European Union since 17 May 2002 as eye drops for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
Opatanol nasal spray was to be used to treat the signs and symptoms of allergic conditions of the nose, rhinitis (sneezing, itchy nose, runny nose and congestion), due to some materials (allergens) from pollens, house dust or animals.
Olopatadine, the active substance in Opatanol, is an antihistaminic. This means that it blocks the action of histamine, a natural substance in the body that is released when the body is exposed to an allergen. By blocking the action of histamine, Opatanol nasal spray was expected to help to control the signs and symptoms of allergic rhinitis.
The effects of the medicine were first tested in experimental models before being studied in humans.
The company submitted the results of clinical studies where Opatanol nasal spray used twice a day was compared to a placebo (a dummy treatment) in the treatment of allergic seasonal rhinitis (hay fever) and in perennial rhinitis. The studies in hay fever lasted two weeks and looked at how the symptoms were improved. The study in perennial rhinitis lasted one year.
The application was at 'day 120' when the company withdrew. The CHMP had formulated a list of questions to be answered by the company, and the company had not yet responded to them.
The CHMP takes up to 210 days to evaluate an application for an extension of a marketing authorisation. Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the company. Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions (at day 180) to be answered by the company in writing or during a hearing. Following CHMP opinion, it usually takes around 2 months for the European Commission to update a licence.
The CHMP had concerns and was of the provisional opinion that Opatanol nasal spray could not be approved, for the treatment of the signs and symptoms of seasonal and perennial rhinitis.
The CHMP wanted to see the effect of Opatanol nasal spray compared to other medicines for the treatment of hay fever and perennial rhinitis.
In addition, the CHMP wanted to see the results of further tests carried out by the company to clarify the potential for harm of impurities contained in Opatanol nasal spray before making its recommendation.
The company's letter of withdrawal is published on the EMEA website and can be found under the tab 'All documents'.
There are no ongoing clinical trials or compassionate use programmes with Opatanol nasal spray in the EU.
Based on the currently available data, the CHMP has no concern regarding the use of Opatanol eye drops.